AstraZeneca halts COVID-19 vaccine trial following adverse reaction in UK participant
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AstraZeneca’s phase 3 trial of a COVID-19 vaccine candidate has been put on hold because of a “suspected serious adverse reaction” in a participant from the United Kingdom, according to a report by STAT.
AstraZeneca began the phase 3 trial in the United States on August 17. According to information available on clinicaltrials.gov, the trial is being held at 62 sites across the U.S., although not all locations have started enrolling participants.
According to STAT, the trials were halted at all locations after a participant in the U.K. trial developed a suspected serious adverse reaction during the trial. In a statement from AstraZeneca issued to STAT, representatives said this is a “routine action” that happens whenever an unexplained illness occurs during a trial.
“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” they wrote. “We are committed to the safety of our participants and the highest standards of conduct in our trials.”
References:
- Clinicaltrials.gov. Phase III double-blind, placebo-controlled study of AZD1222 for the prevention of COVID-19 in adults. https://clinicaltrials.gov/ct2/show/NCT04516746. Accessed on Sept. 9, 2020.
- Robbins R. STAT. AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K. https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/. Accessed on Sept. 9, 2020.
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